Diet-Induced Variability in Appetite (DIVA)

NCT ID: NCT03447600

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-12-12

Brief Summary

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The aim of this study is to test the hypothesis that dietary weight loss (WL) through alternate day fasting (ADF) will enhance appetite control, health markers and wellbeing following WL compared to standard daily calorie restriction (CR).

Detailed Description

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This is a proof of concept randomized controlled trial in which overweight/obese females will be randomised to a dietary weight loss intervention (ADF or CR) to achieve ≥5% WL. Behavioural measures of appetite control including ad libitum intake after a fixed meal, body composition, resting metabolic rate, measured physical activity and daily energy expenditure, sleep quality, hedonic food reward and eating behaviour traits will be assessed before, during and after the WL intervention in those who reach the target weight loss within 12 weeks. After weight loss phase, participants will be given standard healthy eating and physical activity advice for weight maintenance and body weight will be followed up after weight loss at 12 months.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alternate day fasting

Participants randomised to Alternate Day Fasting weight loss intervention. One day fasting of 25% total energy requirements alternated with one day ad libitum intake until study completion at \>/=5% weight loss which is an average of 12 weeks.

Group Type EXPERIMENTAL

Alternate Day Fasting

Intervention Type BEHAVIORAL

25% daily energy requirements every other day until study completion at \>/=5% weight loss which is an average of 12 weeks.

Continuous caloric restriction

Participants randomised to continuous caloric restriction weight loss intervention. Every day intake of 75% total energy requirements until study completion at \>/=5% weight loss which is an average of 12 weeks.

Group Type ACTIVE_COMPARATOR

Continuous dietary restriction

Intervention Type BEHAVIORAL

25% daily energy requirements every other day until study completion at \>/=5% weight loss which is an average of 12 weeks.

Interventions

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Alternate Day Fasting

25% daily energy requirements every other day until study completion at \>/=5% weight loss which is an average of 12 weeks.

Intervention Type BEHAVIORAL

Continuous dietary restriction

25% daily energy requirements every other day until study completion at \>/=5% weight loss which is an average of 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female participants aged between 18 and 55 years at the time of signing informed consent
* BMI of 25.0 - 34.9 kg/m2

Exclusion Criteria

* Significant health problems which in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol
* Currently enrolled in a weight loss programme or following a specific diet plan.
* History of eating disorders including binge eating.
* Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
* Pregnant, planning to become pregnant or breastfeeding
* History of anaphylaxis to food
* Known food allergies or food intolerance
* Smokers and those who have recently ceased smoking (\< 6 months)
* BMI \< 24.9 kg/m2 or \> 35 kg/m2
* Volunteers having lost significant amount of weight in the previous 6 months (± 4kg)
* Volunteers who exercise \> 3 days per week or have significantly changed their physical activity patterns in the past 6 months or who intend to change them during the study
* Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
* Participants who work in appetite or feeding related areas.
* Participants who do shift work
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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Dr Graham Finlayson

Chair in Psychobiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine Beaulieu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Graham Finlayson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Beaulieu K, Casanova N, Oustric P, Turicchi J, Gibbons C, Hopkins M, Varady K, Blundell J, Finlayson G. Matched Weight Loss Through Intermittent or Continuous Energy Restriction Does Not Lead To Compensatory Increases in Appetite and Eating Behavior in a Randomized Controlled Trial in Women with Overweight and Obesity. J Nutr. 2020 Mar 1;150(3):623-633. doi: 10.1093/jn/nxz296.

Reference Type DERIVED
PMID: 31825067 (View on PubMed)

Other Identifiers

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LDS-DIVA-2017

Identifier Type: -

Identifier Source: org_study_id